Senior Director, Statistics

Sagimet Biosciences; Foster City (CA); Vor Ort; USD 150.000 - 200.000; Vollzeit

Zusammenfassung

Sagimet Biosciences seeks a senior Statistician to join its Clinical team in Foster City, CA. You will lead statistical activities across Phase II and Phase III trials, from design to final reporting, in collaboration with Clinical Operations, Regulatory Affairs, and CROs.

Deep biostatistical expertise and strong regulatory knowledge are essential. You will develop SAPs, randomization schemes, and sample size justifications; perform and oversee analyses with SAS/R; contribute to TLFs and

Qualifikationen

• Master's or Ph.D. in Statistics, Biostatistics, or closely related quantitative field required; Ph.D. strongly preferred.
• 7+ years (M.S.) or 5+ years (Ph.D.) of statistical experience in pharma/biotech/CRO with leadership of phase 2/3 programs.
• Proficiency in SAS; experience with R strongly preferred; experience with CDISC data standards and regulatory submission packages.
• Strong knowledge of ICH E9, E9(R1), E6(R2) and FDA/EMA statistical guidance.
• Experience authoring SAPs, CSRs, and regulatory submission documents.
• Ability to manage multiple priorities in a fast-paced environment.

Aufgaben

• Lead statistician for Phase II and Phase III trials across design, analysis, and reporting phases.
• Provide statistical oversight to outsourced Phase 1 trials.
• Develop SAPs, randomization schemes, and sample size justifications.
• Design study protocols with endpoints and estimands; write methodology sections.
• Perform analyses using SAS and/or R; generate TLFs for reports.
• Collaborate with CROs and vendors for statistical work and quality review.
• Contribute to regulatory submissions (INDs, NDAs, BLAs) and FDA/EMA interactions.
• Support data review, CDISC SDTM/ADaM standards, and data management coordination.
• Maintain programming code for reproducible analyses and submission-ready outputs.
• Provide statistical support for DSMB activities and safety-efficacy integration.

Kenntnisse

SAS programming

R programming

Statistical leadership

Regulatory knowledge

Communication with stakeholders

Ausbildung

M.S./Ph.D. in Statistics or Biostatistics

Tools

CDISC SDTM/ADaM

Jobbeschreibung

Description

The Statistician will serve as a core member of Sagimet Biosciences' Clinical team, providing statistical expertise and leadership across Phase II and Phase III clinical trials. Reporting directly to the Chief Medical Officer, this individual will be responsible for the design, analysis, interpretation, and reporting of clinical study data in a manner that meets rigorous scientific and regulatory standards.

This role will operate with a high degree of independence and versatility, collaborating cross-functionally with Clinical Operations, Regulatory Affairs, and external CROs and vendors. This role requires deep technical expertise in biostatistics, a thorough understanding of ICH/FDA/EMA guidelines, and the ability to communicate complex statistical concepts clearly to non-statistical stakeholders.

Essential Responsibilities

• Serve as the lead statistician for Phase II and Phase III clinical trials, providing input throughout the full trial lifecycle from design through final reporting
• Provide input and statistical oversight to outsourced phase 1 clinical trials
• Develop and author Statistical Analysis Plans (SAPs), randomization schemes, and sample size justifications for clinical studies
• Partner with the CMO and Clinical Operations team to design study protocols, including endpoints, estimands, and statistical methodology sections
• Perform and oversee all statistical analyses using SAS and/or R, including primary, secondary, and exploratory analyses
• Generate and validate Tables, Listings, and Figures (TLFs) for interim and final clinical study reports
• Collaborate with CROs and external statistical vendors, providing oversight and quality review of contracted statistical work
• Contribute to the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and briefing documents for FDA/EMA interactions
• Support data review and database lock activities, including coordination with data management on CRF design, edit checks, and CDISC dataset standards (SDTM/ADaM)
• Ensure compliance with applicable regulatory guidelines, including ICH E9, E9(R1), E6(R2), and applicable FDA/EMA guidance documents
• Develop and maintain programming code for reproducible analysis and submission-ready deliverables
• Participate in Data Safety Monitoring Board (DSMB) activities, including providing blinded and unblinded statistical support as appropriate
• Contribute to benefit-risk analyses and integrated summaries of safety and efficacy for regulatory filings
• Support clinical development strategy by providing statistical input on trial design trade-offs, adaptive designs, and go/no-go decision frameworks
• Present statistical methodology and findings to internal leadership, external partners, and regulatory agencies
• Contribute to process improvements, SOPs, and best practices for statistical operations within the company
• Provide cross-functional statistical support to Regulatory Affairs as needed
• Maintain awareness of emerging statistical methods and regulatory trends to advance company capabilities
• Assist with preparation of clinical development plans and integrated evidence packages
• Support inspection readiness activities with respect to statistical documentation and audit trails
• Other duties as assigned

Education and Experience Requirements

• Master's degree (M.S.) or Ph.D. in Statistics, Biostatistics, or a closely related quantitative field required; Ph.D. strongly preferred
• 7+ years (M.S.) or 5+ years (Ph.D.) of statistical experience in a pharmaceutical, biotech, or CRO environment with demonstrated statistical leadership of phase 2 and/or phase 3 programs
• Demonstrated experience supporting Phase II and/or Phase III clinical trials through regulatory submission
• Proficiency in SAS (Base, STAT, GRAPH, MACRO) required; experience with R strongly preferred
• Experience with CDISC data standards (SDTM, ADaM) and regulatory submission packages
• Strong working knowledge of ICH E9, E9(R1) estimands framework, E6(R2) GCP, and FDA/EMA statistical guidance
• Experience authoring or substantially contributing to SAPs, CSRs, and regulatory submission documents
• Ability to work independently and manage multiple priorities in a fast-paced environment